DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed 10/02/25. Claim 1 has been amended, no new claims have been added, and claims 11-43 have been cancelled. Thus, claims 1-10 and 44-52 are presently pending in this application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 7-8, and 50-52 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leonard (2019/0366016).
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Annotated fig 2 of Leonard.
With respect to claim 1, Leonard discloses an adaptor (fig 2) for introducing a nebulized medication into breathing gas for respiratory therapy (see [0039]), the adaptor comprising: a reservoir (320, fig 2) adapted to contain a volume of medication (see [0045]); a vibrating mesh (330, fig 2; see [0045]) disposed at a reservoir outlet of the reservoir (340, fig 2) and adapted to receive a flow of the medication from the reservoir (see [0045]) and output a flow of nebulized medication (see [0045]); a mixing chamber (see annotated fig 2 of Leonard) having: a gas inlet (120, fig 2) adapted to receive a flow of breathing gas (see arrows from 120 upward into chamber in annotated fig 2 of Leonard) from a gas source (see [0041]); a nebulizer inlet (aerosol port; 130, fig 2) adapted to receive the flow of nebulized medication from the vibrating mesh (see [0045]), the vibrating mesh being disposed between the nebulizer inlet and the reservoir outlet (see fig 2); an internal volume (see mixing chamber in annotated fig 2 of Leonard wherein the volume within the space is the internal volume) in fluid communication with the gas inlet and the nebulizer inlet and adapted to allow for mixing of the flow of breathing gas and the flow of nebulized medication to produce a flow of mixed gas (see [0039]); and a mixed gas outlet (400, fig 2) in fluid communication with the internal volume (see arrow flows from internal volume to 400 in fig 2 and [0039]) and adapted to output the flow of mixed gas (see [0040]); and a pressure tap tube (500, fig 2) comprising a first end (510, fig 2) in fluid communication with the gas source (see second flow of breathing gas in annotated fig 2 of Leonard) and a second end (520, fig 2) coupled to the reservoir (see fig 2), the pressure tap tube configured to receive a second flow of breathing gas (see annotated fig 2 of Leonard with the flow of gas labeled), wherein the pressure tap tube is arranged to allow the second flow of breathing as to bypass the mixing chamber (see the second flow outside (bypassing) the mixing chamber in annotated fig 2 of Leonard) in order to pressurize a headspace in the reservoir above the volume of medication (note when the space 150 is empty the second flow of breathing gas communicates with the tube 500, the gas/air in the tube would equalize the reservoir 300 and the mixing chamber; i.e. gas flow through the tube not liquid).
With respect to claim 7, Leonard discloses the pressure tap tube is integrally formed in a wall (see annotated fig 2 of Leonard) connecting the reservoir to the mixing chamber, the wall at least partially defining the nebulizer inlet and positioned adjacent to the vibrating mesh (see location of the wall and mesh and inlet in annotated fig 2 of Leonard).
With respect to claim 8, Leonard discloses the reservoir further comprises a medication inlet (310, fig 2) adapted to receive a refill flow of medication into the reservoir from a medication source (see [0045]).
With respect to claim 50, Leonard discloses the adapter is configured to provide the breathing gas at a flow rate between 8 LPM and 60 LPM (see [0042] where the flow rate is up to 40LPM and thus provided between the claimed range).
With respect to claim 51, Leonard discloses the mixed gas outlet (400, fig 2) is in fluid communication with a nasal cannula (see [0044]) to deliver the flow of mixed gas to a patient ([0052] ‘nebulized and delivered to the patient’).
With respect to claim 52, Leonard discloses the breathing gas is a humidified breathing gas (see [0039]; ‘The breathing gas may be heated and humidified’).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leonard in view of Chen (CN112915347).
With respect to claim 2, Leonard discloses a port of the reservoir (310, fig 2 of Leonard) adapted to convey gas from the pressure tap tube into the headspace (see [0051] and note the gas would enter the tube and travel to the reservoir while the rain out collects) but lacks the second end of the pressure tap tube comprises a connector.
However, Chen teaches a breathing circuit (fig 1; ‘atomization device capable of being connected with a breathing machine’) comprising a reservoir (21, fig 2) with a port (211, fig 2) and a tube (3, fig 2) comprising a connector (33, fig 5) sized to couple to the port of the reservoir in a sealingly manner (see translation of Chen ‘the liquid medicine tube joint 211 is provided with internal threads which are matched with a thread sealing cover 33 to ensure air tightness during atomization’).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the second end of the pressure tap tube to include a connector as taught by Chen so as to allow for easy attachment and reattachment of the tube and provide an air tight connection to avoid loss of gas or medicament.
With respect to claim 3, the modified Leonard shows the connector is a rubber plug having an inner lumen.
With respect to claim 4, the modified Leonard shows a receiver sized to couple to the connector of the second end of the pressure tap tube, the receiver being isolated from the reservoir such that gas does not flow through the pressure tap tube when the connector is coupled to the receiver.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leonard in view of Gallem (2016/0279351).
With respect to claim 5, Leonard discloses all the elements as claimed above but lacks the reservoir comprises a valve adapted to couple to the second end of the pressure tap tube.
However, Gallem teaches an aerosol device (fig 1) comprising a reservoir (1, fig 1) with a valve (see [0136]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the reservoir of Leonard to include a valve as taught by Gallem so as to regulate the fluid flow through the reservoir (see [0136] of Gallem).
Note after the modification the valve is adapted to couple to the second end of the pressure tap tube via the space and the medicament in the reservoir.
With respect to claim 6, the modified Leonard shows the valve is a diaphragm valve (see [0136] of Gallem).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leonard in view of Clancy (2009/0241948).
With respect to claim 9, Leonard shows all the elements as claimed above but lacks the medication inlet comprising a sealing plug.
However, Clancy teaches a breathing circuit (fig 14) with a nebuliser (1, fig 14) with a medication inlet (400, fig 14) comprising a sealing plug (401, fig 14 and [0097]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the medication inlet of Leonard to include a sealing plug as taught by Clancy so as to allow medicament to be introduced to the reservoir and refilled as needed.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leonard (2019/0366016).
With respect to claim 10, Leonard discloses all the elements as claimed above but lacks the pressure tap tube comprises a lumen having an internal diameter between 0.01 in and 0.03 in.
However, it would be an obvious design choice to modify the lumen diameter to be 0.01 to 0.03 in, since such a modification would have involved a mere change in the size of a component. A change in the size is generally recognized as being within the level of one of ordinary skill in the art. It appears the size has no criticality on the adaptor and the modified lumen diameter of Leonard would perform equally as well with a lumen diameter in the claimed range.
Claim(s) 44-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leonard in view of Fink (2007/0267010).
With respect to claim 44, Leonard discloses all the elements as claimed above but lacks a controller operatively coupled to the gas source.
However, Fink teaches a drug delivery system (100, fig 1) with a controller (87, fig 7) adapted to adjust the flow of breathing gas from a first flow rate (begin; see [0097]) to a second flow rate (stop; see [0097]), the second flow rate being lower than the first flow rate (note the beginning of flow would be higher than the stopping of flow (zero)).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the adaptor of Leonard to include a controller as taught by Fink so as to provide synchronized flow to the user making for effective therapy.
With respect to claim 45, the modified Leonard shows the controller is configured to adjust the flow of breathing gas to the first flow rate during a high flow period (beginning flow would be high flow; see [0097] of Fink) and to the second flow rate during a low flow period (stop would be no flow or low flow; see [0097] of Fink).
With respect to claim 46, the modified Leonard shows the low flow period is synchronized with at least an inspiratory phase of breathing of a patient (see [0097] of Fink; stop … in the subsequent inhalation).
With respect to claim 47, the modified Leonard shows the high flow period is synchronized with an expiratory phase of breathing of a patient (see [0097] of Fink; begin aerosolization during exhalation).
With respect to claim 48, the modified Leonard shows the low flow period occurs immediately after the inspiratory phase (see [0097] of Fink; stop … in the subsequent inhalation).
Allowable Subject Matter
Claim 49 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
The arguments to the newly added claim limitations in claims 1-10 and 44-52 have been addressed in the above rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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/KELSEY E BALLER/Examiner, Art Unit 3785
/TU A VO/Primary Examiner, Art Unit 3785